NCT01916486已完成不适用
Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months
研究概览
简要总结
The investigators will conduct a randomized controlled trial study to provide preliminary evidence of efficacy of exercise training or a complex mental and social activities program for improving cognitive function in older adults with chronic stroke, compared with a stretch and relaxation program.
详细描述
A total of 119 adults diagnosed with chronic stroke will be randomized to either a 6-month twice-weekly exercise program, complex mental and social activities program, or stretch and relaxation program. After 6 months of intervention, they will be followed for an additional 6 months. There will be four measurement sessions: baseline, 3 months, 6 months (end of intervention period); and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will specifically recruit individuals who had an ischemic or hemorrhagic stroke and have probable mild cognitive impairment.
- •In addition, individuals must meet the following inclusion criteria:
- •Aged 55 years or over;
- •Have a history of a single stroke of at least one year prior to study enrolment;
- •Mini-Mental State Examination (MMSE) (5) score of ≥ 20 at screening, including a perfect score on the 3-step command to ensure intact comprehension and ability to follow instructions;
- •Have subjective cognitive complaints;
- •Community-dwelling;
- •Lives in Metro Vancouver;
- •Able to comply with scheduled visits, treatment plan, and other trial procedures;
- •Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
- •Stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, rivastigmine, memantine, etc.) that is not expected to change during the 12-month study period, or, if they are not on any of these medications, they are not expected to start them during the 12-month study period;
- •Able to walk for a minimum of six metres with rest intervals with or without assistive devices;
- •Have an activity tolerance of 60 minutes with rest intervals;
- •Not currently participating in any regular therapy or progressive exercise; and
- •Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals.
排除标准
- •Diagnosed with dementia of any type;
- •Diagnosed with another type of neurodegenerative or neurological condition (ie. Parkinson's disease) that affects cognitive function and mobility;
- •At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- •Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician;
- •Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or
- •Have aphasia as judged by an inability to communicate by phone.
研究组 & 干预措施
Exercise training
Experimental
Twice-weekly for the 6-month duration.
干预措施: Exercise training (Behavioral)
Complex mental and social activities
Experimental
Twice-weekly for the 6-month duration.
干预措施: Complex mental and social activities (Behavioral)
Control: stretching and relaxation program
Active Comparator
Twice-weekly for the 6-month duration.
干预措施: Control: stretching and relaxation program (Behavioral)
结局指标
主要结局
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months
时间窗: Baseline and 6 months
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.
次要结局
- Change from baseline in executive functions as measured by the Tower of London Test.(Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months)
- Change from baseline in physical activity level as measured by the Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS).(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in category fluency.(Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months)
- Change from baseline in memory and executive functions as measured by the verbal digits forward and backward tests.(Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months)
- Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in executive functions as measured by the Stroop Test.(Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months)
- Change from baseline in processing speed and executive functions as measured by the Trail Making Tests (Parts A & B).(Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months)
- Change from baseline in community mobility as measured by the Life-space Assessment (LSA).(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in functional capacity as measured by the 6 Minute Walk Test.(Baseline, 3 months, 6 months, and 12 months)
- Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.(Baseline, 3 months, 6 months, and 12 months)
- Change from Baseline in sleep quality as measured by the Motion Watch 8.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in grip strength.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D).(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in quality of life as measured by European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS).(Baseline, 3 months, 6 months, and 12 months)
- Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Cog Plus) at 12 months(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in fatigue as measured by the Fatigue Severity Scale.(Baseline, 3 months, 6 months, and 12 months)
- Change from baseline in quadriceps strength.(Baseline, 3 months, 6 months, and 12 months)
- Change from Baseline in lipid profile.(Baseline and 6 months)
- Change from Baseline in insulin sensitivity.(Baseline and 6 months)
- Health care resource usage.(Baseline, 3, and 6 months)
研究者
Teresa Liu-Ambrose
Principal Investigator
University of British Columbia
研究点 (1)
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